Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | June 2016 |
| Contact: | Laurie Lawler, RN |
| Email: | llawler@partners.org |
| Phone: | 617-525-9731 |
11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary Hypertension
The purpose of this study to look at differences in the way the heart functions in people
with pulmonary hypertension (PH) who have near normal right ventricle (RV) function and
people with pulmonary hypertension who have impaired RV function. The right ventricle is a
chamber of the heart that pumps blood into the pulmonary artery (the artery that carried
blood from the heart to the lungs). Learning more about how the heart is working in people
with pulmonary hypertension may help researchers to understand how to better treat pulmonary
hypertension and prevent the disease from getting worse.
To do this, we will use two imaging techniques, MRI (Magnetic Resonance Imaging) and PET/CT
(Positron Emission Tomography/Computed Tomography). MRI uses a strong magnet and radio waves
to take pictures of your heart. A PET/CT scan combines a PET and CT scan into one machine. A
CT scan uses x-0rays to take a 3-day picture of the inside of your body, while a PET scan
measures small amounts of radiation from a dye called a "tracer" that we inject into your
veins.
You will be given two tracers as part of the PET/CT scan. A tracer is a special type of dye
with a small amount of radioactivity in it. The tracers that are used in this study are
called [18F]fluorodeoxyglucose (FDG) and [11C]-acetate.
In order to take part in this study, you must also have agreed to take part in a companion
study. In the companion study, we are trying to learn whether the drug ranolazine is safe
and effective in people with PH.
with pulmonary hypertension (PH) who have near normal right ventricle (RV) function and
people with pulmonary hypertension who have impaired RV function. The right ventricle is a
chamber of the heart that pumps blood into the pulmonary artery (the artery that carried
blood from the heart to the lungs). Learning more about how the heart is working in people
with pulmonary hypertension may help researchers to understand how to better treat pulmonary
hypertension and prevent the disease from getting worse.
To do this, we will use two imaging techniques, MRI (Magnetic Resonance Imaging) and PET/CT
(Positron Emission Tomography/Computed Tomography). MRI uses a strong magnet and radio waves
to take pictures of your heart. A PET/CT scan combines a PET and CT scan into one machine. A
CT scan uses x-0rays to take a 3-day picture of the inside of your body, while a PET scan
measures small amounts of radiation from a dye called a "tracer" that we inject into your
veins.
You will be given two tracers as part of the PET/CT scan. A tracer is a special type of dye
with a small amount of radioactivity in it. The tracers that are used in this study are
called [18F]fluorodeoxyglucose (FDG) and [11C]-acetate.
In order to take part in this study, you must also have agreed to take part in a companion
study. In the companion study, we are trying to learn whether the drug ranolazine is safe
and effective in people with PH.
Historically, RV failure had been described as a stereotyped response to hemodynamic
overload. More recent large patient cohort data suggests that RV, independently from
Pulmonary Arterial Pressure (PAP), predicts mortality. Thus, a recent hypothesis suggests
that individual genetic differences dysregulate cardiomyocyte function and, in doing so,
predispose to RV failure in humans, control patient-specific manifestations of disease, and
thus would represent key diagnostic markers and therapeutic targets. In fact, multiple key
metabolic regulatory factors have been found to be altered in RV failure, any one of which
could contribute to individual predisposition to RV failure. Based on their established
functions in left ventricular injury and metabolism19 and known alterations in right
ventricular failure20, we propose to evaluate metabolic dysfunction of the RV using positron
emission topography (PET) and cardiac magnetic resonance imaging (CMR).
overload. More recent large patient cohort data suggests that RV, independently from
Pulmonary Arterial Pressure (PAP), predicts mortality. Thus, a recent hypothesis suggests
that individual genetic differences dysregulate cardiomyocyte function and, in doing so,
predispose to RV failure in humans, control patient-specific manifestations of disease, and
thus would represent key diagnostic markers and therapeutic targets. In fact, multiple key
metabolic regulatory factors have been found to be altered in RV failure, any one of which
could contribute to individual predisposition to RV failure. Based on their established
functions in left ventricular injury and metabolism19 and known alterations in right
ventricular failure20, we propose to evaluate metabolic dysfunction of the RV using positron
emission topography (PET) and cardiac magnetic resonance imaging (CMR).
Inclusion Criteria:
- Participation in the companion treatment protocol "A randomized, double-blind,
placebo-controlled, multi-center study to assess the effect of ranolazine on outcomes
in subjects with pulmonary hypertension and right ventricular dysfunction accompanied
by a comparative study of cellular metabolism in subjects with pulmonary hypertension
with and without right ventricular dysfunction".
Exclusion Criteria:
- Pregnancy or lactation: Women of childbearing potential must have a negative urine or
blood pregnancy test on the day of the PET/CT scan.
- Anxiety or claustrophobia prohibiting completion of imaging
- Inability to tolerate imaging procedures (up to 2 hours on scanner)
- Moderate to severe chronic renal disease defined as an estimated glomerular
filtration rate < 30 ml/min/1.73m2
- Implantable cardioverter-defibrillator, pacemaker, hazardous metallic implants or any
other contraindication to MRI
- History of uncontrolled diabetes mellitus with fasting glucose > 150 mg/dL at the
treatment protocol screening visit.
We found this trial at
1
site
75 Francis street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Aaron Waxman, MD,PhD
Phone: 617-525-9731
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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